Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

NCT00386763

Malaria Falciparum

COMPLETED PHASE3

Efficacy of Artemether-Lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 12 Years at Four Sentinel Sites in Mozambique

NCT06970600

Malaria (Uncomplicated)

COMPLETED NA

Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

NCT01619878

Acute Uncomplicated Falciparum Malaria

COMPLETED PHASE2/PHASE3

Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.

NCT02089841

Plasmodium Falciparum Malaria

COMPLETED PHASE4

Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania

NCT00454961

Malaria

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria, Falciparum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type ACTIVE_COMPARATOR

Artemether/lumefantrine tablets

Intervention Type DRUG

Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine

Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets

Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2

B

Group Type ACTIVE_COMPARATOR

Artemether/Lumefantrine suspension

Intervention Type DRUG

Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension

Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml

Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Artemether/lumefantrine tablets

Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine

Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets

Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2

Intervention Type DRUG

Artemether/Lumefantrine suspension

Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension

Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml

Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Coartem Co-Artesiane suspension

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children aged between 6 and 59 months
* Minimum body weight of 5kg
* Presence of fever (Temp \>/= 37.5°C) or a history of fever in the last 24 hours
* Presence of asexual P. falciparum monoinfection
* Initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood
* Not suffering from severe and complicated forms of malaria
* Able to take drugs under study by the oral route
* Parent or guardian gives informed written consent to participate in study

Exclusion Criteria

* Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb =/\<5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (\>200,000 µl)
* Patients treated with mefloquine, halofantrine within the 7 days before Day 0 or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0
* Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria
* Patients with vomiting and/or diarrhoea
* Signs of severe malnutrition (defined as follows: children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)
* Presence of general danger signs in children below 5 years or other signs of serious and complex Plasmodium falciparum, as stated in the present WHO definitions
* Patients with known history of heart disease or arrhythmia
* History of allergy to artemether/lumefantrine or quinine

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No